Monday, April 05, 2010

Clinical Trial of Liquid Nicotine Cigarettes Yields Greater than 50% Quit Rate at 3 Months; Suggests Great Promise for Liquid & Electronic Cigarettes

A single-arm phase 2a clinical trial of liquid nicotine cigarettes demonstrated a 3-month smoking cessation rate of 53%, suggesting that liquid and electronic cigarettes have great promise as being truly effective devices to help people quit smoking (see: Geimer N, Olson CE, Baumgarten D, Kepner JL, Mahoney MC. Use of a liquid nicotine delivery product to promote smoking cessation. BMC Public Health 2010, 10:155).

According to the article: "A single-arm Phase 2a study was conducted. Community-based smokers (ages 18+ years, smoking at least 10 cigarettes daily for the past year and interested in making a quit attempt) were recruited and completed clinic visits at 2 week intervals over the 12 week study period where carbon monoxide levels were assessed and the Smoke Break product was rated on taste and overall satisfaction. Participants were provided with a supply of liquid nicotine cigarettes (e.g., Smoke Break) at each clinic visit. A total of 69 smokers were enrolled and received the intervention product (intention to treat group, ITT) and 52 smokers verified participation (according to protocol group, ATP). The cessation rate at 12 weeks after the baseline visit, assessed as the bioverified point prevalence of abstinence, was 71.1% (95% confidence interval [CI] 58.8%-83.5%) in the ATP group and 53.6% (41.8%-65.4%) in the ITT group. Participants rated the liquid nicotine delivery system highly and also expressed general satisfaction. Few adverse events were identified with no serious adverse events."

The study concludes: "These results support the efficacy of the liquid nicotine delivery system in smoking cessation. If this nicotine delivery product proves to be effective in larger trials, it could represent an inexpensive, readily accessible and well-tolerated agent to promote smoking cessation."

The Smoke Break cigarette is a clear tube resembling a cigarette which contains a liquid gel. Users consume the gel by sipping through a mouthpiece. The gel contains nicotine and cherry flavoring. According to the manufacturer: "The hand-to-mouth motion replicates what smokers do when they are smoking."

The Rest of the Story

These results confirm the argument I made in previous commentaries about electronic cigarettes: that cigarette addiction is a behavioral addiction as well as a pharmacologic one, and that the failure to recognize this important fact is hindering efforts to develop effective smoking cessation treatments.

The tobacco control movement is obsessed with nicotine delivery as the sole element of smoking cessation treatment, completely ignoring the fact that smoking is a behavior, not merely a method of inhaling nicotine. The behavioral elements of smoking - including the holding of the cigarette and moving it to the mouth - are important components of the addiction and any effort that ignores these elements is likely to fail.

This explains, I believe, why nicotine replacement therapy and other pharmaceutical treatments for what is viewed as "nicotine addiction" have such low rates of effectiveness. It also explains the anecdotal evidence that electronic cigarettes are very effective in helping many vapers stay off cigarettes. And now, it also explains the tremendous success of liquid cigarettes in this clinical trial.

The effectiveness of liquid cigarettes in this trial is impressive. The three-month, confirmed, point abstinence rate of 53.6% is the highest such rate for any smoking cessation product. It is much higher than the three-month cessation rate reported for the nicotine patch or nicotine gum and higher than the corresponding rate for Chantix.

The three-month point abstinence among smokers who confirmed using the liquid cigarettes was actually 71.1%, a striking figure given the power of cigarette addiction.

Clearly, the liquid cigarette and electronic cigarettes deserve further study to confirm their safety and effectiveness. These products could truly be life savers.

This research adds to the evidence supporting the use of electronic cigarettes as a safer alternative to help smokers quit and demonstrates that those who are trying to ban e-cigarettes are supporting an action which would severely harm the public's health.

It confirms that something other than an evidence-based concern for the public's health is motivating those who are trying to ban electronic cigarettes.

Personally, I believe that the idea that a person would go through motions that look like smoking is too much for most anti-smoking groups and advocates to take. We are finding out that it is not the health hazards of smoking, but the act of smoking itself, which is disturbing to anti-smoking groups.

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